REVERTIDINE- atipamezole hydrochloride injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ATIPAMEZOLE HYDROCHLORIDE (UNII: 2W4279571X) (ATIPAMEZOLE - UNII:03N9U5JAF6)

Available from:

Modern Veterinary Therapeutics LLC

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION

Therapeutic indications:

REVERTIDINE is indicated for the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride, and medetomidine hydrochloride in dogs. Since atipamezole is always used concomitantly with dexmedetomidine or medetomidine, it should not be used in dogs with the following conditions: cardiac disease, respiratory disorders, liver or kidney diseases, dogs in shock, severely debilitated dogs, or dogs stressed due to extreme heat, cold or fatigue. Administration of atipamezole is contraindicated in dogs with a known hypersensitivity to the drug.

Product summary:

REVERTIDINE is supplied in 10-mL, multidose vials containing 5.0 mg of atipamezole hydrochloride per mL. Read

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

REVERTIDINE- ATIPAMEZOLE HYDROCHLORIDE INJECTION, SOLUTION
MODERN VETERINARY THERAPEUTICS LLC
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REVERTIDINE
ANADA #200-624, Approved by FDA
REVERTIDINE
(atipamezole hydrochloride)Sterile Injectable Solution - 5.0 mg/mL
Dexmedetomidine and Medetomidine Reversing Agent
For intramuscular use in dogs only
CAUTION
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION
REVERTIDINE (atipamezole hydrochloride) is a synthetic alpha
2-adrenergic antagonist.
The chemical name is
4-(2-ethyl-2,3-dihydro-1H-inden-2-yl)-1H-imidazole hydrochloride.
The molecular formula is C
H N • HCl and structural formula is:
Each mL of REVERTIDINE contains 5.0 mg atipamezole hydrochloride, 1.0
mg methylparaben (NF),
8.5 mg sodium chloride (USP), and water forinjection (USP).
INDICATIONS
REVERTIDINE is indicated for the reversal of the sedative and
analgesic effects of dexmedetomidine
hydrochloride, and medetomidine hydrochloride in dogs.
DOSAGE AND ADMINISTRATION
REVERTIDINE is administered intramuscularly (IM) for reversal of
sedation and analgesia regardless
of the route used for dexmedetomidine or medetomidine. The atipamezole
dose for the reversal of IV
14
16
2
2
dexmedetomidine or medetomidine is 3750 mcg/m .
The atipamezole dose for the reversal of IM dexmedetomid.i ne or
medetomidine is 5000 mcg/m .
The dosage of REVERTIDINE is calculated based on body surface area.
Use the following tables to
determine the correct injection volume or the correct REVERTIDINE
dosage on the basis of kilograms
of body weight.
Note that the mcg/kg dosage decreases as body weight increases.
2
2
CONTRAINDICATIONS
Since atipamezole is always used concomitantly with dexmedetomidine or
medetomidine, it should not
be used in dogs with the following conditions: cardiac disease,
respiratory disorders, liver or kidney
diseases, dogs in shock, severely debilitated dogs, or dogs stressed
due to extreme heat, cold or
fatigue.
Administration of atipamezole is contraindicated in dogs with a known
hypersensitivity to